DEVICE: Silverstone Titanium Interbody Fusion System (B417SP301007T21)
Device Identifier (DI) Information
Silverstone Titanium Interbody Fusion System
SP301007T2
In Commercial Distribution
Altus Spine, LLC
SP301007T2
In Commercial Distribution
Altus Spine, LLC
30L PLIF Titanium Silverstone-P
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57805 | Metallic spinal fusion cage, non-sterile |
A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral fusion device with bone graft, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K171329 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 10 Millimeter |
Height: 7 Millimeter |
Length: 30 Millimeter |
Device Record Status
1666f7f1-5936-462d-be10-685ff6ce32ac
July 06, 2018
3
September 01, 2017
July 06, 2018
3
September 01, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
GS1 | 00843210109428 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(610)355-4156
Info@altus-spine.com
Info@altus-spine.com